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5% minoxidil hair regrowth serum with biotin - Medication Information

Product NDC Code 83767-401
Drug Name

5% minoxidil hair regrowth serum with biotin

Type Brand
Pharm Class Arteriolar Vasodilation [PE],
Arteriolar Vasodilator [EPC]
Active Ingredients
Biotin .5 g/100ml
Minoxidil 5 g/100ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 2691097
Application Number 505G(a)(3)
Labeler Name Guangzhou Ruijiu Electronic Technology Co., Ltd.
Packages
Package NDC Code Description
83767-401-01 1 bottle in 1 package (83767-401-01) / 100 ml in 1 bottle
83767-401-02 2 bottle in 1 package (83767-401-02) / 100 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Minoxidil 5% Biotin 0.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Apply3-6 drops Minoxidil Serum directly onto scalp on the hair loss area,(3-4 drops for women, 5-6 drops for men). Massage with your hands for 1 minute. After massaging, wash your hands thoroughly. Used once daily on clean dry hair for best results.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Alcohol Panthenol Glycerin Anhydrous citric acid Polysorbate 60 Carbomer homopolymer Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use to regrow hair on the scalp and promote beard growth for men.

Purpose

Information about the drug product’s indications for use.
Hair regrowth treatment

Spl product data elements

Usually a list of ingredients in a drug product.
5% Minoxidil Hair Regrowth Serum With Biotin Minoxidil POLYSORBATE 60 GLYCERIN BIOTIN BIOTIN MINOXIDIL MINOXIDIL ANHYDROUS CITRIC ACID WATER ALCOHOL PANTHENOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
label label2

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
5% Minoxidil Hair Regrowth Serum With Biotin

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
You have no family history of hair loss. Your halr loss is sudden and/or patchy. Your hair loss is associated with childbirth. You do not know the reason for your hair loss. You are under 18 years of age, Do not use on babies and children. Your scalp is red, inflamed,infected, irritated, or painful. You use other medicines on the scalp.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
lf swallowed,get medical help or contact a Poison Control Center (1-800-222-1222)right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
lf chest pain, rapid heartbeat, faintness, or dizziness occurs. lf sudden,unexplained weight gain occurs. lf your hands or feet swell. if scalp irritation or redness occurs. lf you get unwanted facial hair growth occurs. lf you do not see hair regrowth in 4 months.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
Avoid contact with eyes.In case of accidental contact, rinse eyeswith a large amountof cool tap water. You need fo use this product once a day for best results.Theamount of hair regrowth varies for each person.

Storage and handling

Information about safe storage and handling of the drug product.
Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 10'C to 25°℃ (50°F to 77°F)Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°C)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
For extérnal use only. Keep out of reach of children.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API